Jane Kaye

Biography

Prof. Jane Kaye DPhil, LLB, Grad Dip Leg, BA is the Director of the Centre for Law, Health and Emerging Technologies (HeLEX) in the Faculty of Law at the University of Oxford and also leads a research team with Associate Professor Mark Taylor, at the Centre for Health, Law and Emerging Technologies at Melbourne Law School, University of Melbourne, Australia. Her teams consist of lawyers and sociologists who use mixed-method empirical approaches combined with legal analysis to explore the relationships between law, governance and best practice in the area of health. She obtained her degrees from the Australian National University (BA); University of Melbourne (LLB); and University of Oxford (DPhil). She was admitted to practice as a solicitor/barrister in 1997. Within the Oxford Faculty of Law she co-leads the Health, Law and Technology Research Group with Professor Justine Pila and also holds Associate Professorships at the Faculty of Law, University of Tasmania and at the Bioethics Centre, led by Professor Kazuto Kato at the Osaka Medical School, Japan.

Professor Kaye is on a number of international expert committees and scientific advisory boards and has been on the Nuffield Council Bioethics Working Group on Biodata and Rapporteur for the EC Expert Report, Biobanks for Europe - A Challenge for Governance, June 2012. Most recently she was on the UN Taskforce on Health Data Privacy, appointed to the Scientific Advisory Board of the European biobanking platform BBMRI-ERIC, and is on the WP8 Advisory Group of the Joint European Action TEHDAS ‘Towards a European Health Data Space’. She is also on the editorial boards of Genomic Medicine, Law, Innovation and Technology, the Journal of Law, Information and Science, New Genetics & Society and Life Sciences, Society and Policy. The main focus of her research is on digital innovation with an emphasis on digital privacy and dynamic consent, public involvement and engagement in research, biobanks, genomics, data-sharing frameworks, global governance and translational research. She is very interested in supervising students who would like to focus on these areas or any other area of innovation in health.

Publications

Selected publications

J Kaye, EA Whitley, D Lund and M Morrison, 'Dynamic consent: A patient interface for twenty-first century research networks' (2014) 23 European Journal of Human Genetics

DOI: 10.1038/ejhg.2014.71

Journal Article (60)

J Kaye, Prictor, M.,, Huebner, S. and Teare, H. J. A., 'Australian Aboriginal and Torres Strait Islander Collections of Genetic Heritage: The Legal, Ethical and Practical Considerations of a Dynamic Consent Approach to Decision Making.' (2020) Journal of Law, Medicine and Ethics

DOI: 10.1177/1073110520917012

J Kaye, de Neiva Borba, M., , ., Hoppe, N., Garani-Papadatos, T., Negri, S., . . . Phillips, A. , Joly, Y. and Rial-Sebbag, E, 'Direct to Participant Participation Country Reports: The United Kingdom ' (2020) Journal of Law, Medicine and Ethics

DOI: 10.1177/1073110519897736

Prictor, M., Lewis M.A., Newson, A. J. and J Kaye, 'Dynamic Consent: An Evaluation and Reporting Framework' (2020) Journal of Empirical Research on Human Research Ethics

DOI: 10.1177/1556264619887073

Dynamic consent (DC) is an approach to consent that enables people, through an interactive digital interface, to make granular decisions about their ongoing participation. This approach has been explored within biomedical research, in fields such as biobanking and genomics, where ongoing contact is required with participants. It is posited that DC can enhance decisional autonomy and improve researcher–participant communication. Currently, there is a lack of evidence about the measurable effects of DC-based tools. This article outlines a framework for DC evaluation and reporting. The article draws upon the evidence for enhanced modes of informed consent for research as the basis for a logic model. It outlines how future evaluations of DC should be designed to maximize their quality, replicability, and relevance based on this framework. Finally, the article considers best-practice for reporting studies that assess DC, to enable future research and implementation to build upon the emerging evidence base.

Morrison, M. , Mourby, M., Gowans, H. and J Kaye, 'Governance of research consortia: challenges of implementing Responsible Research and Innovation within Europe. ' (2020) Life Sciences, Society and Policy

DOI: 10.1186/s40504-020-00109-z

Hamakawa, N. Kogetsu, A., Nakano, R., Kogetsu, A. and J Kaye, 'Landscape of participant-centric initiatives for medical research in the United States, the United Kingdom, and Japan: Scoping review' (2020) Journal of Medical Internet Research

DOI: 10.2196/16441

Teare, H. J. A. , Prictor, M., J Kaye and Kaye, J. , 'Reflections on dynamic consent in biomedical research: the story so far.' (2020) European journal of Human Genetics

DOI: 10.1038/s41431-020-00771-z

Dynamic consent (DC) was originally developed in response to challenges to the informed consent process presented by participants agreeing to ‘future research’ in biobanking. In the past 12 years, it has been trialled in a number of different projects, and examined as a new approach for consent and to support patient engagement over time. There have been significant societal shifts during this time, namely in our reliance on digital tools and the use of social media, as well as a greater appreciation of the integral role of patients in biomedical research. This paper reflects on the development of DC to understand its importance in an age where digital health is becoming the norm and patients require greater oversight and control of how their data may be used in a range of settings. As well as looking back, it looks forwards to consider how DC could be further utilised to enhance the patient experience and address some of the inequalities caused by the digital divide in society.

J Bell, S Aidinlis, H Smith and J Kaye, 'Balancing data subjects' rights and public interest research: Examining the interplay between UK Law, EU Human Rights Law and the GDPR' (2019) 5 European Data Protection Law Review 43

DOI: 10.21552/edpl/2019/1/8

D Nicol, L Eckstein, HB Bentzen and J Kaye and others, 'Consent insufficient for data release' (2019) 364 Science 445

DOI: 10.1126/science.aax0892

Mourby, M. , Aidinlis, S., Gowans, H. and J Kaye, 'Governance of academic research data under the GDPR—lessons from the UK. ' (2019) International Data Privacy Law

DOI: 10.1093/idpl/ipz010

J Kaye, A Phillips, H Gowans and N Shah, 'International Direct-to-Participant (DTP) Genomic Research: The United Kingdom Responses (Country Reports)' (2019) 47 The Journal of Law, Medicine & Ethics 683

DOI: 10.1177/1073110519897736

J Bell, S E Wallace, M Mourby and J Kaye, 'Lawful disclosure of administrative data for research purposes in the UK' (2019) 2 Journal of Data Protection & Privacy

N Shah, V Coathup, H Teare and J Kaye and others, 'Motivations for data sharing - views of research participants from four European countries: a DIRECT study' (2019) 27 European Journal of Human Genetics 721

DOI: 10.1038/s41431-019-0344-2

M Mourby, E Mackey, M Elliot and J Kaye and others, 'Are 'pseudonymised' data always personal data? Implications of the GDPR for administrative data research in the UK' (2018) 34 Computer Law & Security Review: The International Journal of Technology Law and Practice 222

DOI: 10.1016/j.clsr.2018.01.002

M Prictor, H Teare, J Bell and J Kaye, 'Consent for data processing under the General Data Protection Regulation: Could ‘dynamic consent’ be a useful tool for researchers?' (2018) 3 SSRN Electronic Journal

DOI: 10.2139/ssrn.3222394

J Kaye, SF Terry and E Jeungst and others, 'Including all voices in international data-sharing governance' (2018) 12 Human Genomics

DOI: 10.1186/s40246-018-0143-9

Budin-Ljosne, H Teare, J Kaye and J Kaye and others, 'Dynamic Consent: a potential solution to some of the challenges of modern biomedical research' (2017) 18 BMC Medical Ethics 4

DOI: 10.1186/s12910-016-0162-9

C Mitchell, C Ploem, V Chico and J Kaye and others, 'Exploring the potential duty of care in clinical genomics under UK law' (2017) 17 Med Law Int 158

DOI: 10.1177/0968533217721966

D Sipp, Tcaulfield, J Kaye and J Kaye, 'Marketing of unproven stem cell-based interventions: A call to action' (2017) Science Translational Medicine 1

DOI: 10.1126/scitranslmed.aag0426

V Coathup, N Hamakawa, T Finlay and J Kaye, 'Participant-centric initiatives and medical research: Scoping review protocol' (2017) 6 JMIR Res Protoc

DOI: 10.2196/resprot.7407

NAA Giesbertz, K Melham, J Kaye and J Kaye, 'Personalized assent for pediatric biobanks' (2017) 12 BMC Medical Ethics 59

M F. Bin Abdul Azi, M Morrison and J Kaye, 'Regulating human stem cell research and therapy in low- and middle-income countries: Malaysian perspectives' (2017) New Genetics and Society

DOI: 10.1080/14636778.2017.1415137

M Morrison, J Bell, C George and J Kaye, 'The European General Data Protection Regulation: Challenges and considerations for iPSC researchers and biobanks' (2017) 12 Regenerative Medicine

DOI: 10.2217/rme-2017-0068

H Teare, J Hogg and J Kaye and others, 'The RUDY study: using digital technologies to enable a research partnership' (2017) 25 European Journal of Human Genetics 816

DOI: 10.1038/ejhg.2017.57

J Kaye, L Briceño Moraia, C Mitchell and J Bell, 'Access governance for biobanks: The case of the BioSHaRE-EU cohorts' (2016) 14 Biopreservation and Biobank 201

DOI: 10.1089/bio.2015.0124

J Bell, M Ancillotti, V Coathup and J Kaye and others, 'Challenges and opportunities for ELSI Early Career Researchers' (2016) 17 BMC Medical Ethics

DOI: 10.1186/s12910-016-0121-5

JP Woolley, ML McGowan, H Teare and J Kaye and others, 'Citizen science or scientific citizenship? Disentangling the uses of public engagement rhetoric in national research initiatives' (2016) 17 BMC Medical Ethics 33

DOI: 10.1186/s12910-016-0117-1

J Kaye, L Briceño Moraia, L Curren and J Bell, 'Consent for biobanking: The legal frameworks of countries in the BioSHaRE-EU project' (2016) 14 Biopreserv ation and Biobank 195

DOI: 10.1089/bio.2015.0123

D Chalmers, D Nicol, J Kaye and J Bell, 'Has the biobank bubble burst? Withstanding the challenges for sustainable biobanking in the digital era' (2016) 17 BMC Medical Ethics 39

DOI: 10.1186/s12910-016-0124-2

J Kaye and The 1000 Genome Project Consortium, 'A global reference for human gentic variation' (2015) 526 Nature

DOI: 10.1038/nature15393

J Kaye and The UK10K Consortium, 'Improved imputation of low-frequency and rare variants using the UK10K haplotype reference panel' (2015) 6 Nature Communications

DOI: 10.1038/ncomms9111

J Kaye, D Muddyman, C Smee and J Bell, 'Pop-up' governance: Developing internal governance frameworks for consortia: The example of UK10K' (2015) Life Sciences, Society and Policy 10

DOI: 10.1186/s40504-015-0028-9

J Kaye and The UK10K Consortium, 'The UK10K project identifies rare variants in health and disease' (2015) 526 Nature

DOI: 10.1038/nature14962

J Kaye and The UK10K Consortium, 'Truncation of POC1A associated with short stature and extreme insulin resistance' (2015) 55 Journal of Molecular Endocrinology

DOI: 10.1530/jme-15-0090

J Kaye and The UK10K Consortium, 'Whole-genome sequence-based analysis of thyroid function' (2015) 6 Nature Communications

DOI: 10.1038/ncomms6681

J Kaye and The UK10K Consortium, 'A rare variant in APOC3 is associated with plasma triglyceride and VLDL levels in Europeans' (2014) Nature Communications

DOI: 10.1038/ncomms5871

J Kaye, 'Data sharing policy design for consortia: Challenges for sustainability' (2014) Genome Medicine

DOI: 10.1186/gm523

J Kaye, EA Whitley, D Lund and M Morrison, 'Dynamic consent: A patient interface for twenty-first century research networks' (2014) 23 European Journal of Human Genetics

DOI: 10.1038/ejhg.2014.71

J Kaye and The 1000 Genome Project Consortium, 'Integrating sequence and array data to create an improved 1000 Genomes Project haplotype refence panel' (2014) Nature Communications

DOI: 10.1038/ncomms4934

J Kaye, 'Managing clinically significant findings in research: The UK10K example' (2014) European Journal of Human Genetics

DOI: 10.1038/ejhg.2013.290

K Melham, LB Moraia, C Mitchell and J Kaye, 'The evolution of withdrawal: negotiating research relationships in biobanking' (2014) 10 Life Sciences, Society and Policy

DOI: 10.1186/s40504-014-0016-5

J Kaye, N Kanellopoulou, N Hawkins and H Gowans, 'Can I access my personal genome? The current legal position in the UK' (2013) 22 Medical Law Review 64

DOI: 10.1093/medlaw/fwt027

J Kaye, 'ELSI 2.0 for genomics and society' (2013) Science

DOI: 10.1126/science.1218015

J Kaye and The 1000 Genome Project Consortium, 'An integrated map of genetic variation from 1,092 human genomes' (2012) 491 Nature

DOI: 10.1038/nature11632

J Kaye, 'Embedding biobanks as tools for personalised medicine' (2012) Norsk Epidemiologi

DOI: 10.5324/nje.v21i2.1490

J Kaye, 'From patients to partners: Participant-centric initiatives in biomedical research' (2012) Nature Reviews Genetics

DOI: 10.1038/nrg3218

J Kaye, 'The tension between data sharing and and the protection of privacy in genomics research' (2012) Annual Review of Genomics and Human Genetics

DOI: 10.1146/annurev-genom-082410-101454

P Boddington, L Curren, J Kaye and J Kaye, 'Consent forms in genomics: The difference between law and practice' (2011) 18 European Journal of Health Law 329

DOI: 10.1163/157180911X598744

J Kaye, 'From single biobanks to international networks: Developing e-governance' (2011) Human Genetics

J Kaye and The 1000 Genome Project Consortium, 'A map of human genome variations from population-scale sequencing' (2010) Nature

DOI: 10.1038/nature09534

J Kaye, 'Ethhical implications of the use of whole genome methods in medical research' (2010) European Journal of Human Genetics

DOI: 10.1038/ejhg.2009.191

L Curren, J Kaye, H Gowans and P Boddington, 'Identifiability, Genomics and UK Data Protection Law' (2010) 17 Eurpean Journal of Health Law 329

J Kaye, 'Data sharing in genomics - re-shaping scientific practice' (2009) Nature Reviews Genetics

DOI: 10.1038/nrg2573

J Kaye and Toronto Int Data Release Workshop, 'Prepublication data sharing' (2009) 461 Nature

DOI: 10.1038/461168a

J Kaye, 'Mapping the regulatory space for genetic databases and biobanks in England and Wales' (2008) Medical Law International

J Kaye, 'The regulation of direct-to-consumer genetic tests' (2008) Human Molecular Genetics

DOI: 10.1093/hmg/ddn253

J Kaye, 'Patents and translational research in genomics' (2007) Nature Biotechnology

DOI: 10.1038/nbt0707-739

J Kaye, 'Do we need a uniform regulatory system for biobanks across Europe?' (2006) European Journal of Human Genetics

DOI: 10.1038/sj.ejhg.5201530

J Kaye, 'Genetic research on the UK population - do new principles need to be developed?' (2001) Trends in Biotechnology

J Kaye, 'Report may lead to population collection by the back door' (2001) 323 British Medical Journal

DOI: 10.1136/bmj.323.7313.632

J Kaye, 'Safeguards for research using large scale DNA collections' (2000) British Medical Journal

Report (1)

S Coy, H Teare, S Aidinlis and J Kaye, Data Policy Models for Funding Bodies (Wellcome Trust 2018)

Chapter (3)

J Kaye, J Bell and M Prictor, 'Trends and challenges in biobanking, tensions and and traumas in health law' in I Freckelton and K Petersen (eds), Tensions and Traumas in Health Law (The Federation Press 2017)

N Hawkins, N Kanellopoulou, J Kaye and J Kaye and others, 'Ownership of biomedical information in biobanks' in Pascuzzi G | Izzo U | Mailotti M. (ed), Comparative Issues in the Governance of Research Biobanks (Springer 2013)

DOI: 10.1007/978-3-642-33116-9-5

J Kaye, 'Biobanking networks - What are the governance challenges?' in (ed), Principles and practice in biobank governance (Stanger 2009)

Other (3)

C Johnston, J Kaye and J Bell, 'Who owns your DNA?' (2017) Pursuit (Melbourne University) Legal Affairs

J Kaye, J Bell and L Briceño Moraia, 'Biobank Report: United Kingdom' (2016) 44 J Law Med Ethics 96

DOI: 10.1177/1073110516644202

J Kaye, 'The use of biological sample collections and personal medical information in human genetics reasearch: Issue for social science research and public policy' (1999) Wellcome Trust